A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06878261Tipo: INTERVENTIONALInicio: 25 de mar de 2025Fin estimado: 5 de jun de 2029

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Resumen

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Descripción detallada

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

≥40 to ≤80 years old
COPD diagnosis ≥1 year,
Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy
EOS ≥ 150 cells/μL during screening
CAT ≥15 at screening
Former or current smokers ≥10 pack-years

Criterios de exclusión

Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
Asthma, incl. pediatric, or ACOS
Any unstable disorder that can impact participants safety or study outcomes
Tuberculosis requiring treatment within 12 months prior V2
Malignancies current or past
Concomitant therapies:
Macrolides (less than 6 months)
Systemic immuno-suppressive, -modulating medications
LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT

Intervenciones

CONTACT

information.center@astrazeneca.com 1-877-240-9479

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